Users Manual Part 1
1. Safety Information
User Manual of Mars1417X
25
Mars1417X is indicated for digital imaging solutions designed to provide general radiographic
diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace
film/screen systems in all general–purpose diagnostic procedures. The device is not intended for
mammography or dental applications.
Suitablepatient
It is suitable for providing digital X-ray imaging for DR system to provide general radiographic
diagnosis for human anatomy including both adult and pediatric patients, but not intended for
mammography or dental applications. The remaining notes depend on the DR system.
PATIENTpopulation:
Adult and pediatric patients
Weight: not relevant
Health: not relevant
Nationality: multiple
Patient state: patient is not user
Gender: except for pregnant women
PediatricUse:Guidance&Considerations
Special care should be exercised when imaging patients outside the typical adult size range,
especially smaller pediatric patients whose size does not overlap the adult size range (e.g.less
than 50 kg (110 lb) in weight and 150 cm (59 in) in height, measurements which approximately
correspond to that of an average 12 year old.
The following ranges of pediatric subpopulations are to be used as a guide for manufacturers in
developing medical devices:
Pediatric Subgroup
A
pproximate Age Range
Newborn (Neonate) From birth to 1 month of age
Infant Greater than 1 month to 2 years of age